The allowance of applications for Supplementary Protection Certificates (SPCs) in Europe is governed by Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (the SPC Regulation), rulings of the Court of Justice of the European Union (CJEU), and the interpretation of these by national courts. In particular, the development of CJEU case law has a direct and significant effect on the protection obtainable for pharmaceutical products across Europe. In this article, we discuss two recent cases of the CJEU that have affected what protection is obtainable.

First, we discuss C-673/18 (Santen) and the resulting U-turn the CJEU has made regarding second medical use SPCs.

Second, we discuss the continuing evolution of case law regarding the interpretation of Article 3(a) of the SPC Regulation, relating to protection by the basic patent, and how with every clarification, new questions arise.

The end of second medical use SPCs: Santen C-673/18

A clarification of SPC law at the expense of research into new therapeutic indications?

Ever since the CJEU handed down its judgement in C-130/11 (Neurim), there has been ambiguity as to what extent “second medical use SPCs” should be considered allowable. In this context, second medical use SPCs are SPCs that protect products that have received market authorisation for a specific therapeutic indication, where market authorisation for a product comprising the same active ingredient is in existence already.

In a rare move, the CJEU has now overturned the ruling in Neurim, closing the door to second medical use SPCs and providing some much needed clarity regarding the application of Article 3(d) of the SPC Regulation. But does this new ruling make the SPC Regulation unfit for purpose?

The CJEU’s ruling and its history are discussed here.

C-130/11 (Neurim)

At the heart of the Neurim ruling is an SPC application for Neurim’s melatonin medicine Circadin® and whether it should be allowable in light of a previously granted market authorisation for a product comprising the same active ingredient for use in a different therapeutic indication. Article 3(d) of the SPC Regulation requires that the medicinal product that is the subject of the SPC application be covered by a valid market authorisation, specifically “the first authorisation to place the product on the market as a medicinal product”.

Neurim obtained market authorisation for the use of Circadin® in treating insomnia in humans. The previous market authorisation was granted for a product (Regulin®) comprising the same active ingredient for use in controlling reproduction in sheep. Taking a literal interpretation of Article 3(d) and Article 1(b) of the SPC Regulation, it could be reasoned that the first market authorisation for Regulin® would preclude the grant of the SPC for Circadin®.

That is, if the medicinal product of Article 3(d) is interpreted literally in accordance with Article 1(b) as “the active ingredient or combination of active ingredients of a medicinal product”, then a market authorisation for Regulin® would preclude the grant of a later SPC for a product comprising the same active ingredient (Circadin®), regardless of the therapeutic indication. This approach is consistent with earlier CJEU rulings.

In contrast, the Neurim ruling determined that the “first market authorisation” of Article 3(d) in fact related to the first market authorisation for an application that falls within the scope of the basic patent relied upon for the SPC application in question. The CJEU reasoned:

“…the mere existence of an earlier MA [market authorisation] obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that that application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.”

It follows that a market authorisation for a product for use in controlling reproduction in sheep does not preclude the grant of an SPC based on a patent and market authorisation relating to the use of the same product for use in treating insomnia in humans.

This decision therefore made available the possibility of obtaining second medical use SPCs, provided that they were for “a different application” and that “that application is within the limits of the protection conferred by the basic patent […]”. While this may be in keeping with the ethos of the SPC Regulation (to ensure sufficient protection to encourage pharmaceutical research), the interpretation of these terms has been contested ever since (see, for example, our earlier reporting on C-443/17, Abraxis Bioscience).

C673/18 (Santen)

A chance to question and clarify the Neurim ruling arose from the rejection of a French SPC application for Ikervis® (a medicine comprising ciclosporin for use in the treatment of keratitis, a condition causing inflammation of the eyeball). Ikervis® obtained market authorisation on 19 March 2015, however, an earlier market authorisation had been granted in 1983 for Sandimmun® (a medicine comprising ciclosporin for multiple therapeutic applications, including endogenous uveitis – an inflammation of a portion of the eyeball).

The French National Industrial Property Institute (INPI) rejected the application reasoning that the existence of the market authorisation for Sandimmun® precluded the grant of an SPC for Ikervis® under Article 3(d) of the SPC Regulation. The INPI’s ruling reasoned that the ‘different application’, as stated in the Neurim ruling, should be interpreted narrowly to mean use in new therapeutic field or so that the active ingredient acts in a different way to that of the first market authorisation. The INPI ruled that this was not satisfied in the present case and rejected the SPC application for Ikervis®. Santen appealed the decision to the Court of Appeal, Paris who referred questions to the CJEU.

In its decision, the CJEU stated that “the term ‘product’ is understood to mean an active ingredient in the strict sense and that minor changes to the medicinal product such as a new dose, the use of a different salt or ester or even of a different pharmaceutical form will not lead to the issue of a new SPC.” This is consistent with previous rulings, such as C-431/04 (Massachusetts Institute of Technology) and C-443/17 (Abraxis Bioscience).

The CJEU continued to reason that because the wording of Article 3(d) of the SPC Regulation refers to authorisation to place the product on the market (and does not refer to the limits of the basic patent as required by Neurim) and because the term “product” must be interpreted strictly, that:

“the first market authorisation for the product as a medicinal product […] means the first MA [market authorisation] for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue […], irrespective of the therapeutic application of that active ingredient, or of that combination of active ingredients, in respect of which that was obtained.”

In other words, a first market authorisation for an active ingredient precludes the grant of an SPC based on a later market authorisation for that same active ingredient, regardless of the therapeutic use of the active ingredient.

This is of course a blow to certain pharmaceutical companies who, since Neurim, have been applying for second medical use SPCs to protect their significant investments in developing new therapeutic uses of known active ingredients. Following Santen, these applications and SPCs will be vulnerable to invalidation and generic competition, which will necessitate further expenditure on the parts of these pharmaceutical companies. It seems that new therapeutic indications of active ingredients – an area of innovation protected by patent law at the European Patent Office – will no longer be afforded the protection that first indications can obtain via national SPCs in Europe.

Article 3(a) and functional claims: C-650/17 Royalty Pharma

The building case law regarding Article 3(a) of the SPC Regulation has been further clarified by C-650/17 (Royalty Pharma).

As reported in our earlier articles, the CJEU’s ruling in C-121/17 (Gilead) provided a degree of clarification and certainty regarding whether a “product is protected by a basic patent in force” (as required by Article 3(a) of the SPC Regulation). Specifically, Gilead provided a test for determining whether a combination of active ingredients is considered ‘protected’ by the basic patent in question.

Now the CJEU, in C-650/17 (Royalty Pharma), has confirmed and clarified this test (at least in relation to claims using functional definitions), making an important contribution to the current case law, while at the same time opening the door to further requests for clarification.

The Road to Royalty Pharma: Interpretations of Article 3(a)

Prior to Royalty Pharma, the following CJEU decisions had opined on the interpretation of Article 3(a). The divergent interpretations had led to divergent SPC requirements in European countries over time.

C-322/10 (Medeva): Article 3(a) of the SPC Regulation “must be interpreted as precluding the competent industrial property office of a Member State from granting a supplementary protection certificate relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the application for such a certificate.”

C-443/12 (Actavis): “the basic objective of Regulation No 469/2009 [SPC Regulation] is to compensate for the delay to the marketing of what constitutes the core inventive advance that is the subject of the basic patent”.

C-493/12 (Eli Lilly): “it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the European Patents Office, Article 3(a) of that regulation does not, in principle, preclude the grant of a supplementary protection certificate for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the Convention on the Grant of European Patents and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court.”

C-557/13 (Actavis): “the holder of a patent should enjoy an extended monopoly only for the development of a product which is the true subject-matter of the invention covered by the patent in question, that is to say, for its technical contribution or core inventive advance.”

C-121/17 (Gilead): (i) “the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent,” and (ii) “each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.”

Out of these, the most recent Gilead ruling provided a somewhat clearer test for determining the requirements of Article 3(a). However, the application of the totality of the case law has resulted in further requests for clarification from the CJEU.

Royalty Pharma

One such request comes in the following questions referred by the Bundespatentgericht (German Federal Patent Court):

  1. “Is a product protected by a basic patent in force pursuant to Article 3(a) of Regulation [No 469/2009] only if it forms part of the subject matter of protection defined by the claims and is thus provided to the expert as a specific embodiment?
  2. Is it not therefore sufficient for the requirements of Article 3(a) of Regulation [No 469/2009] if the product in question satisfies the general functional definition of a class of active ingredients in the claims, but is not otherwise indicated in individualised form as a specific embodiment of the method protected by the basic patent?
  3. Is a product not protected by a basic patent in force under Article 3(a) of Regulation [No 469/2009] if it is covered by the functional definition in the claims, but was developed only after the filing date of the basic patent as a result of an independent inventive step?”

In answering the first and second questions together, the CJEU stated that Article 3(a) of the SPC Regulation:

“must be interpreted as meaning that a product is protected by a basic patent in force, within the meaning of that provision, if it corresponds to a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent, but is not otherwise indicated in individualised form as a specific embodiment of the method of that patent, provided that it is specifically identifiable […]”.

This not only confirms that the two-pronged test of Gilead applies to products covered by functional claims, but also clarifies that the product does not need to be individualised as a specific embodiment in the basic patent.

The CJEU continued to state that the product must be specifically identifiable:

“In the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.”

While this wording corresponds closely to the EPO’s disclosure requirement, the CJEU also stated “where the product is not explicitly disclosed by the claims of the basic patent, but is covered by a general functional definition, […] a person skilled in the art must be able to infer directly and unambiguously from the specification of the patent as filed that the product which is the subject of the SPC comes within the scope of the protection afforded by that patent.” This wording corresponds directly to that used by the EPO. However, there is no further guidance provided on how strictly this test should be applied (the EPO, for example, applies this requirement strictly).

In answering the third question, the CJEU noted that for a product falling under a functional definition in the claims, the question is whether that product is also ‘specifically identifiable’. However, Article 3(a) of the SPC Regulation should not be interpreted as protecting a product covered by the functional definition in the claims, if:

“It was developed after the filing date of the application for the basic patent, following an independent inventive step.”

Although the CJEU did not provide guidance on how the ‘independent inventive step’ should be ascertained, this important clarification does leave the door open to products covered by a functional definition in the claims, where they were developed after the filing of the basic patent, provided they were not obtained by an independent inventive step.

As such, the ruling in Royalty Pharma has moved the case law forward (explicitly rejecting the ‘core inventive advance’ test of Actavis and confirming and clarifying the Gilead approach), whilst inviting further questions and clarification. For example, expect to see development regarding the interpretation of: how to strictly apply the ‘specifically identified’ test; what constitutes an ‘inventive step’ and what makes it ‘independent/autonomous’; what does ‘developed’ mean and when can this development occur; and whether the requirements of this ruling should be extended to Markush type claims.

If you have any questions regarding the practical handling of SPC applications, the validity of granted SPCs and/or the developing case law, please get in contact with a member of our pharmaceutical team.